Helixmith's US Regulatory Head Dr. Tu Doan Visits Korea... "Discussing NGENSIS Issues"
[Asia Economy Reporter Jang Hyowon] Dr. Thu Doan, who oversees the Regulatory Affair division at Helixmith in the United States, arrived in Korea on the 15th to begin full-scale work. Dr. Doan plans to discuss and decide on various issues related to the FDA and regulatory matters concerning Engensis (VM202).
The Phase 3-2 clinical trial for diabetic peripheral neuropathy (DPN) of Engensis, conducted by Helixmith in the U.S., is approaching its conclusion, with less than a year remaining until the results are announced. Engensis is a first-in-class innovative drug in the pharmaceutical field. It is notably the first regenerative medicine and the first gene therapy in the fields of neuropathy and pain. Accordingly, the various regulatory requirements necessary for market approval differ significantly from those of conventional pharmaceuticals. During this visit, Dr. Doan plans to collaborate with the company's experts and management to determine strategies required for market approval and proactively prepare the necessary data and information.
Standards and testing methods related to the production of Engensis are also key issues. Engensis is a pharmaceutical product using plasmid DNA and is expected to be the first of its kind to apply for market approval in the U.S. Therefore, Helixmith is effectively setting industry standards. Although Helixmith has closely consulted with the U.S. FDA so far, with the major clinical trial nearing completion, Dr. Doan’s visit to Korea will allow for a detailed review of the requirements necessary for market approval preparation.
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Dr. Doan graduated from the University of Missouri-Kansas City School of Pharmacy and has been an expert working in the regulatory field. Over the past 15 years, she has worked at U.S. biotech companies such as Biogen Idec, Allergan, and Kite Pharma, which is famous for the first CAR-T product market approval.
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